Darzalex: how was the first human dose set?

The public FDA and EMA reviews of Darzalex don't say how the first human dose was chosen. That rationale is in the IND, which is confidential, so it is missing for most approved products.

In cancer patients the start dose should be pharmacologically active yet reasonably safe. A common small-molecule approach is one-tenth of the dose severely toxic to 10% of rodents, or one-sixth of the highest non-severely toxic dose in non-rodents.

NOAEL / key findings: Chimpanzee: infusion-related reactions, thrombocytopenia, anemia, leukopenia and elevated AST (FDA pharmacology/toxicology review, p. 7)

Full method, every step sourced →